One Drop wants to help lead a healthcare revolution for people with diabetes – here’s how


One DropWhen Jeff Dachis was diagnosed with Type I diabetes four years ago, he remembers leaving the doctor’s office with a sinking feeling in his chest.

“I had about six minutes with a nurse practitioner and was given an insulin pen and a prescription and a pat on the back – and I was out the door,” he told Drug Delivery Business News. “I was concerned for my family, I was concerned for my kids. I didn’t really know what this was going to mean for me.”

He found himself searching for devices or products to help him manage his diabetes. From counting carbohydrates to calculating insulin doses, diabetes is a data-driven disease.

Get the full story at our sister site, Drug Delivery Business News.

House passes DoD bill with room to renegotiate drug, device approval provision


DoD, Pentagon

The US House of Representatives this week passed a nearly $700 billion defense policy bill, but left room for negotiating new terms related to a controversial provision which would have given the Dept. of Defense the power to approve medical devices and drugs without FDA clearance.

The house voted 356 to 70 to approve the $692 billion National Defense Authorization Act, but left room to renegotiate and narrow the provision before the legislation is passed on to the Senate, according to a report from The Hill.

The House approved a rule on Tuesday that requests that the House clerk not send the bill forward until the chamber approves a separate bill to refocus the provision, according to the report.

House Armed Services Committee Chairman Mac Thornberry (R-Texas) and ranking committee member Rep. Adam Smith (D-Wash.) said they support a compromise to allow for expedited FDA approval in military medical emergencies in place of giving the Pentagon the authority to approve drugs and devices that had not been cleared by the agency.

“Although we still have concerns about the impact it would have on our men and women in the field, we are content to let this compromise move forward in hopes of improvement. To be clear, if the Armed Services Committee does not see evidence that the FDA is doing a better job meeting the needs of our troops, we will not hesitate to take action,” Thornberry and Smith said in a joint statement, according to The Hill.

The provision to the bill last week alarmed congressional health staff and the Dept. of Health and Human Services who claim it could erode medical safety, putting US soldiers at risk, according to the report.

FDA chief to big pharma: ‘End the shenanigans’


prescription drugsFDA commissioner Dr. Scott Gottlieb yesterday scolded pharmaceutical companies that employ tactics to stifle generic drug competition, calling on them to “end the shenanigans.”

At this week’s Federal Trade Commission meeting on competition within the pharmaceutical industry, the FDA chief called out brand-name pharma companies for trying to extend negotiations over risk evaluation and mitigation strategies, or REMS, to stall generic companies from buying a product to run bioequivalence studies.

Get the full story at our sister site, Drug Delivery Business News.

House punts med device tax until after tax reform is finished


Capitol Hill

The US House of Representatives will not be considering the 2.3% medical device tax in its new push for tax reform, promising to attend to them after the reform effort is finished, according to a Washington Examiner report.

Both the medical device tax and taxes on health insurers which were part of Obamacare will be left off the table until after tax reform efforts are finished, according to the report.

House Ways and Means Committee Chair Kevin Brady (R-Texas) said the taxes would be brought up “separately and immediately after conclusion of our tax reform efforts,” according to the Examiner.

The House is hopeful it will pass its tax overhaul by Thanksgiving, with the Ways and Means Committee holding a 4-day hearing to mark up the bill with changes and amendments, according to the report.

In August, a coalition of conservative action groups jumped on the bandwagon for repealing the medical device tax, urging Congressional leaders to scrap the levy.

Value-based care: CMS’s new administrator wants more of it

CMS Seema-Verma

Seema Verma, CMS’s administrator

Seven months into her tenure, CMS administrator Seema Verma is turning out to be highly supportive of value-based care models. In fact, she recently told an audience in Cleveland that she wants them implemented faster.

The situation appears to dispel doubts that alternative payment models – such as Accountable Care Organizations or “comprehensive care” models for such big-ticket items as joint replacements – would remain a priority under President Donald Trump’s administration. The move toward paying for “value” versus the old fee-for-service models are a big deal for the medical device industry, which have been shifting their strategies and focus in response.

Alternative payment methods are important for driving innovation and driving value and cost-effective care, Verma said during an appearance at the annual Cleveland Clinic Medical Innovation Summit, which took place Oct. 23–25 in Cleveland. Different models will help drive the market toward value and quality and away from a fee-for-service system, according to Verma, who shared the stage with Cleveland Clinic CEO Toby Cosgrove.

Get the full story on our sister site, Medical Design & Outsourcing.

Could their be a bipartisan Obamacare fix?

bipartisan Obamacare fixRepublican efforts to repeal and replace the Affordable Care Act appear to be dead – at least for now. But two U.S. senators may soon unveil a bipartisan proposal to make modest healthcare fixes.

Sen. Lamar Alexander (R-Tenn.), chairman of the Senate Health, Education, Labor, and Pensions Committee, and Sen. Patty Murray (D-Wash.), the committee’s ranking member, are back at work negotiating a bipartisan plan, according to reports in The Hill, Politico and elsewhere.

Alexander told Politico on Sept. 29 that there might be a piece of legislation ready for Senate leaders by the end of this week.

The deal reportedly would safeguard Obamacare exchange subsidies, which President Donald Trump’s administration has threatened to pull, while giving states more leeway when it comes to the ACA’s requirements. States could potentially have more freedom to offer cheaper, less generous plans on the insurance exchanges.

Whether the proposal will gain traction is anyone’s guess, though Trump has started to show a willingness to sometimes cut deals with Democrats.

Repealing and replacing the Affordable Care Act was a top priority for Trump and the Republican Congress. But as Trump famously (or infamously) said last February as the debate heated up, “Nobody knew health care could be so complicated.” With an end-of-September deadline looming, Republicans made a last push in September with the Graham-Cassidy bill, but the bill was pulled Sept. 26.

Efforts to repeal and replace received another blow on Sept. 29 when Tom Price resigned from his post as U.S. health and human services secretary. Price – a longtime ACA critic when he was a U.S. representative from Georgia – had been a point person for rolling back executive branch efforts to promote Obamacare.

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Tom Price is out as HHS secretary

Rep. Tom Price HHSTom Price has resigned from his post as U.S. health and human services secretary after days of fending off criticism over chartered flights he took on the public dime.

The announcement today out of the White House said Don J. Wright – presently assistant secretary for health and director of the Office of Disease Prevention and Health Promotion – will take over as acting secretary.

The announcement came soon after President Donald Trump, at his Bedminster, N.J. gold course, told reporters that he didn’t like the “optics” around the hundreds of thousands of taxpayer dollars spent on Price’s flights – and that he was “not happy,” according to media reports in the Washington Post, Associated Press and elsewhere. Trump had publicly expressed similar unhappiness earlier this week.

Price yesterday tried to defuse the scandal by offering to personally pay for the cost of his seat on the planes. The distances of some flights had been as short at Washington, D.C. to Philadelphia.

“All of my political career I’ve fought for the taxpayers,” Price said in an HHS news release. “It is clear to me that in this case, I was not sensitive enough to my concern for the taxpayer.”

Price’s statement was apparently not enough. His departure throws another wrench into Trump and congressional Republicans’ efforts to repeal and replace the Affordable Care Act.

Price – a longtime ACA critic when he was a U.S. representative from Georgia – had been a point person for rolling back executive branch efforts to promote Obamacare while his former GOP colleagues in Congress tried to kill and replace the program for good. The future of both efforts is now unclear.

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Bipartisan ‘Problem Solvers’ healthcare reform bill would kill medtech tax

A new bipartisan effort from the US Congress’ Problem Solvers Caucus that looks to alter Obamacare includes a provision to eliminate the 2.3% medical device tax, according to a Finger Lakes Times report.

The movement has received support from democratic Colorado Gov. John Hickenlooper and Repub. Ohio Gov. John Kasich, who said they are looking for a plan to stabilize the healthcare markets and lower insurance premiums, according to the report.

“It is a great day for American when we put aside our political differences and put Americans first. The Problem Solvers Caucus, in conjunction with governors Kasich and Hickenlooper, demonstrated to our colleagues that only by working together can we solve America’s problems. Looking forward, we are already working on tax reforms that will remove the shackles from American business and unleash the innovation and optimism that drive America,” Congressman Tom Reed (R-N.Y.) said, according to the paper.

The removal of the 2.3% device tax would benefit medical device developers, as currently the costs associated with the tax are passed on to the consumers, the caucus claims.

The group has a number of other recommendations for improving the healthcare system in the US, including a commitment that the Trump administration agree to cost-sharing reduction payments and the adoption of a temporary stability fund by congress to create reinsurance programs and reduce premiums.

The plan would encourage insurance companies to enter underserved areas by exempting insurance tax on exchanges in those regions. The individual mandate would be retained, at least for now, and younger people would be encouraged to get insurance to help balance the system, according to the report.

Cost-sharing reduction payments would be moved under congressional oversight, and dedicated stability funds would be formed to reduce premiums and limit losses for providing coverage, specifically targeting individuals with pre-existing conditions.

The employer mandate would be moved from 50 employees at 30 hours to at least 500 employees at 40 hours, according to the report.

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Trump proposes deep cuts to Medicaid, NIH funding


Capitol HillPresident Donald Trump’s proposed budget would slash Medicaid funding and cut support for major biomedical research programs at the National Institutes of Health and the Centers for Disease Control & Prevention.

The budget blueprint drew condemnation from healthcare advocates and lawmakers from both sides of the aisle. Senate majority whip Sen. John Cornyn (R-Texas) reportedly said earlier this week that Medicaid cuts wouldn’t get through Congress.

“I think the tradition is presidents write budget proposals and that the Senate and the House substitute their own, and so I wouldn’t expect that would carry the day,” he told The Hill.

The potential $610 billion cut to Medicaid would add to the $839 billion cut proposed by the American Health Care Act that passed in the House earlier this month.

The proposal to slash Medicaid funding goes against Trump’s campaign promise to leave Medicaid, Medicare and Social Security funds untouched.

Among the more significant reductions proposed in Trump’s budget are an -19% cut to the National Cancer Institute and a -28% cut to spending on environmental health. The budget would also trim funding for the National Science Foundation by $776 million, or -11%.

According to the president’s proposal, the FDA would receive $1.89 billion in direct government funding. The 31% decrease would be offset by an increase of $1.3 billion in user fees.

Rep. Tom Cole (R-Okla.) said the proposed $5.8 billion cut to NIH funding “penny-wise and pound-foolish”, according to Stat. Cole is the chair of the House health appropriations subcommittee.

The proposal did not include any direct cuts to Medicare.

CDC director Dr. Tom Frieden took to Twitter to respond to the administration’s proposal, calling it an “assault on science.”

Also today, Rep. Tom Macarthur (R-NJ) resigned as co-chairman of the so-called Tuesday Group, a caucus of moderate House Republicans, citing divisions over efforts to repeal and replace former President Barack Obama’s healthcare law, according to a report from Politico. 

Republicans are stuck on healthcare but they have no choice but to persevere

Republican health analysts said party officials had little choice but to keep trying to reach consensus — or at least enough consensus to pass a bill out of the House.